(Eagle News) – Pfizer-BioNTech has already submitted its application for emergency use authorization (EUA) for the use of its vaccines to children aged 5 to 11 years old, and is now being evaluated by the Philippine vaccine experts’ panel, according to Food and Drug Administration chief Undersecretary Eric Domingo.
Pfizer’s application has already been forwarded to the country’s vaccine experts for their evaluation as of late last week.
Domingo said that Pfizer claims its vaccine efficacy for children in this age group is 90.7 percent based on their clinical trial data.
In a Laging Handa press briefing, the FDA administrator said that the Philippines would most lifely follow the dosing amount and interval being used by other countries for Pfizer vaccines for this age group, 5 to 11. The amount would depend on the size of the child, he said.
“Kaya lang dahil siyempre kapag bata, mas maliit iyong amounts na kailangan, iyong preparation ay nag-iiba rin pati iyong concentration ng preparation,” Domingo said on Monday, Dec. 13.
“So hindi po siya, iyong ginagamit sa adult tapos kukonti ang amount na ini-inject ano kung hindi it’s a different formulation, iba po iyong concentration per ml na gagawin doon sa mga pambata at iba rin po iyong amount na i-inject sa mga batang maliliit,” he said.
He noted that Pfizer doses are being administered to children in this age group in the US, Europe, Canada and Australia. They are using two doses for children, but set from three or four weeks apart such as the dosing interval in the US, to as far as eight weeks apart in the case of Australia.
Domingo said that they will be observing the efficacy as well as the safety of this vaccines for the younger age group.
“So continuing po talaga ang evaluation at as we get more data, doon po natin ibabase iyong magiging final recommendation po natin,” he said during the briefing.
-Vaccines’ safety-
The most important thing is the vaccines’ safety, he said.
“Ang primary concern po natin lalo na as children get younger ‘no and smaller is iyong safety; before the efficacy, iyon po munang safety ang tinitingnan ng atin pong eksperto diyan bago natin payagan,” the FDA chief said.
So far, the clinical trial data show there is no severe adverse effects so far for the vaccines’ use on children. Most of the effects after vaccination are the usual mild side effects, he said.
Still, the FDA will be strictly monitoring the vaccines in case they are approved for rollout to children aged 5 to 11.
“So ito po, titingnan natin ito during the evaluation and of course, sakali naman na i-rollout natin, continuously din po talaga ang monitoring. Dahil under EUA, talaga pong kasama po talaga roon maigting na pagbabantay to make sure lamang na kung mayroong mga unusual tayo na nakikita ay nahuhuli po natin agad,” Domingo said.
(Eagle News Service)
